Operational Compliance Specialist

About the Role

The Operational Compliance Specialist position supports safe, efficient, innovative, compliant and cost‑effective operation of all GMP buildings at Genentech’s Oceanside, CA campus. The role ensures full compliance with current Good Manufacturing Practices, corporate principles, quality policies and standards, and implements compliance programs, audits, training and investigations. Day‑to‑day activities include developing and maintaining compliance policies, conducting audits, collaborating across teams to resolve issues, staying current with regulatory changes, delivering training, and maintaining accurate documentation. The specialist also serves as a backup GMP supervisor and supports the GMP pest‑control program. • Develop and implement compliance policies and procedures aligned with regulations. • Conduct audits and assessments to identify compliance issues and risks. • Collaborate with internal teams to address concerns and implement corrective actions. • Monitor regulatory changes and ensure company‑wide compliance. • Provide compliance training and guidance to employees. • Maintain qualifications as a Qualified OJT Trainer and generate training compliance reports. • Investigate compliance violations and support disciplinary actions. • Maintain accurate records and documentation of compliance activities. • Participate in industry forums and stay informed on best practices. • Review documentation promptly per relevant SOPs. • Lead continuous improvement projects to enhance compliance processes. • Serve as backup GMP supervisor when needed. • Support GMP pest‑control program, perform audits, and generate quarterly reports.

Key Responsibilities

• ▸compliance audits
• ▸policy development
• ▸regulatory monitoring
• ▸training delivery
• ▸record keeping
• ▸gmp supervision

What You Bring

Candidates must have at least two years of experience in compliance, risk management or related regulatory functions within pharmaceutical, biotechnology, cosmetics or manufacturing environments, be familiar with cGMPs and FDA guidelines, and possess strong written and verbal communication skills. Preferred experience includes working directly with regulatory agencies and bilingual capabilities. • Minimum 2 years experience in compliance, risk management, or regulatory roles within pharma, biotech, cosmetics, or manufacturing. • Familiarity with cGMPs and FDA guidelines. • Strong written and verbal communication skills; ability to explain complex regulations to diverse audiences. • Experience interacting with regulatory agencies or conducting regulatory examinations (preferred). • Bilingual capabilities to support diverse client and tenant populations (preferred).

Requirements

• ▸2 years
• ▸compliance
• ▸cgmp
• ▸fda
• ▸communication
• ▸bilingual

Benefits

The position is full‑time, on‑site in Oceanside, CA with a dayshift schedule. On‑call support may be required outside normal hours, and occasional access to a clean‑room environment with gowning is necessary. Visa sponsorship is not available; candidates must be authorized to work in the United States. Estimated total compensation ranges from $81,000 to $87,000 per year. JLL offers a supportive culture and comprehensive benefits that prioritize mental, physical and emotional health, including a 401(k) plan with matching, medical/dental/vision coverage, paid parental leave at full salary, paid time off, company holidays and early access to earned wages through Daily Pay. The company also leverages AI to match candidates with opportunities and maintains rigorous privacy protections. • 401(k) plan with company matching contributions. • Comprehensive medical, dental, and vision coverage. • Paid parental leave at 100% salary. • Paid time off and company holidays. • Early access to earned wages via Daily Pay.

Work Environment

Onsite